ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry

Terminated

• Conditions: Cartilage Injury; Cartilage Damage
• Interventions: Other: Articular cartilage repair

• Registration Number: NCT04301258
• Lead Sponsor: AlloSource

Brief Summary

The primary objective of this registry is to obtain long-term outcomes on ProChondrix CR in cartilage repair procedures of the knee, ankle, foot and hip.

Detailed Description

This multi-center, observational registry will be used to evaluate the effectiveness of ProChondrix CR in patients who undergo treatment for an articular cartilage defect in the knee, ankle, foot or hip.

This registry will be performed at up to 30 clinical sites across the United States.

Patient follow-up will occur following an articular cartilage repair procedure in which the patient receives ProChondrix CR. During this follow-up period, each patient will be evaluated at least four (4) times at: 3, 6, 12 and 24 months after surgical intervention and will continue annually for as long as patients are willing to fill out questionnaires and outcomes assessments up to 10 years post operatively.

Study Timeline

• Study Start: 2020-01-06
• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-10
• Primary Completion: 2023-09-14
• Study Completion: 2023-09-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Diagnosed by physician to have a cartilage defect in the knee, ankle, foot or hip that requires surgical intervention;
• Will be having, or has had, a cartilage repair procedure using ProChondrix CR;
• Has the ability to understand the requirements of the registry, to provide written informed consent and to comply with the registry protocol;

Exclusion Criteria

• Is a ward of the state, prisoner, or transient.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Articular Cartilage Defect of the Ankle	Articular cartilage repair	Patients, who undergo an articular cartilage repair of the ankle using ProChondrix CR.
Articular Cartilage Defect of the Knee	Articular cartilage repair	Patients, who undergo an articular cartilage repair of the knee using ProChondrix CR.
Articular Cartilage Defect of the Foot	Articular cartilage repair	Patients, who undergo an articular cartilage repair of the foot using ProChondrix CR.
Articular Cartilage Defect of the Hip	Articular cartilage repair	Patients, who undergo an articular cartilage repair of the hip using ProChondrix CR.

Primary Outcome Measures

Name	Time	Method
Long-Term Outcomes of ProChondrix CR	10 Years Post-Operative	Obtain long-term results on patients who have undergone an articular cartilage repair procedure using ProChondrix CR, as assessed by patient reported outcomes.

Trial Locations

Locations (5)

University of Southern Alabama; 🇺🇸 Mobile, Alabama, United States

Beacon Orthopaedics & Sports Medicine; 🇺🇸 Cincinnati, Ohio, United States

CAO Research Foundation; 🇺🇸 Washington, District of Columbia, United States

Rocky Mountain Foot and Ankle Center; 🇺🇸 Wheat Ridge, Colorado, United States

University of Kentucky Research Foundation; 🇺🇸 Lexington, Kentucky, United States